Melatonin and Sleep Spindles in Autism

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05716906

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Dietary Supplement: Melatonin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

The Effects of Melatonin on Sleep Spindles in Children With Autism

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin 5mg melatonin gummy 30 min before bedtime for 2 consecutive nights	Dietary Supplement: Melatonin 5mg gummy 30 min before bedtime for 2 consecutive nights

Arm

Intervention/Treatment

Experimental: Melatonin

5mg melatonin gummy 30 min before bedtime for 2 consecutive nights

Dietary Supplement: Melatonin

5mg gummy 30 min before bedtime for 2 consecutive nights

Outcome Measures

Primary Outcome Measures

Change in sleep spindle density [Five nights of sleep over two weeks]
Changes in sleep spindle density (#/min) during non-Rapid Eye Movement (NREM) sleep between baseline and melatonin nights as measured by portable EEG device.

Secondary Outcome Measures

Change in sleep quality [Five nights of sleep over two weeks]
Change in sleep quality between baseline and melatonin nights

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female subjects with ASD
12-18 years of age
English speaking
Able to understand and respond to questionnaires in English

Exclusion Criteria:

Pregnant or breastfeeding
Substance abuse or dependence within the past six months (nicotine abuse or dependence is not exclusionary)
Chronic medical conditions that affect sleep
Any unstable chronic medical condition such as asthma, diabetes, cystic fibrosis, or cardiac disease
History of head injury resulting in prolonged loss of consciousness or other neurological sequelae
IQ <70
Other neurological disorder, including seizure disorder
Diagnosed sleep disorder
Known genetic causes of ASD
Currently taking melatonin or those who have had an adverse reaction to melatonin in the past

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator: Dara Manoach, PhD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dara S. Manoach, PhD, Professor, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05716906

Other Study ID Numbers:

2021P002832

First Posted:

Feb 8, 2023

Last Update Posted:

Feb 10, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dara S. Manoach, PhD, Professor, Massachusetts General Hospital

Melatonin

Additional relevant MeSH terms:

Autistic Disorder

Autism Spectrum Disorder

Melatonin

Study Results

No Results Posted as of Feb 10, 2023